Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT03268356
Eligibility Criteria:
Inclusion Criteria:
1. Subject is a postmenopausal female
2. Subject has a low-energy fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
3. Subject is ≥ 65 years of age.
4. Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study.
5. Subject is capable of giving written informed consent to participate in the study.
Exclusion Criteria:
1. Subject has a prior diagnosis of secondary osteoporosis.
2. Subject has history of any hip surgery or previous hip fracture in the non-fractured hip.
3. Subject has progressive increase in undiagnosed hip pain over the previous six (6) months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. osteoarthritis, fracture, etc.).
4. Subject has serum calcium levels outside the normal lab range as per local guidelines and reference ranges.
5. Subject has moderate to severe renal insufficiency as per local guidelines and reference ranges.
6. Subject has insulin-dependent diabetes mellitus (IDDM).
7. Subject has Body Mass Index (BMI) \> 30.
8. Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator\*.
9. Subject exhibits excessive alcohol consumption as determined by the principal investigator\*.
10. Subject has radiological evidence of gross bony or joint pathology of the non-fractured hip.
11. Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months.
12. Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months.
13. Subject has history of metabolic bone disease other than osteoporosis (eg. Paget's disease).
14. Subject has a history of auto-immune arthritic diseases including rheumatoid, psoriatic, or those associated with systemic lupus erythematosus, spondyloarthropathy, Reiter's Syndrome or Crohn's Disease.
15. Subject has a history of radiation therapy to the hip or pelvic region.
16. Subject has history of chemotherapy treatment for any condition within the previous five years.
17. Subject has history of any diagnosis and treatment of malignancies (excluding basal cell carcinoma) within the previous five years.
18. Subject has known allergies to implanted device.
19. Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.
20. Subject is currently enrolled in another clinical study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
65 Years
Study:
NCT03268356
Study Brief:
Protocol Section:
NCT03268356